JUDGMENT OF THE COURT (Grand Chamber)

14 July 2022 ([\*](#Footnote*))

(Action for annulment – Law governing the institutions – Regulation (EU) 2018/1718 – Location of the seat of the European Medicines Agency (EMA) in Amsterdam (Netherlands) – Article 263 TFEU – Admissibility – Interest in bringing proceedings – Locus standi – Direct and individual concern – Decision adopted by the Representatives of the Governments of the Member States in the margins of a Council meeting in order to determine the location of the seat of an EU agency – Absence of binding effects in the EU legal order – Prerogatives of the European Parliament)

In Joined Cases C‐106/19 and C‐232/19,

ACTIONS for annulment under Article 263 TFEU, brought on 11 February 2019 and 14 March 2019,

**Italian Republic,** represented by G. Palmieri, acting as Agent, and by C. Colelli, S. Fiorentino and G. Galluzzo, avvocati dello Stato (C‐106/19),

**Comune di Milano,** represented by J. Alberti, M. Condinanzi, A. Neri and F. Sciaudone, avvocati (C‐232/19),

applicants,

v

**Council of the European Union,** represented by M. Bauer, J. Bauerschmidt, F. Florindo Gijón and E. Rebasti, acting as Agents,

**European Parliament,** represented by I. Anagnostopoulou, A. Tamás and L. Visaggio, acting as Agents,

defendants,

supported by:

**Kingdom of the Netherlands,** represented by M.K. Bulterman and J. Langer, acting as Agents,

**European Commission,** represented by K. Herrmann, D. Nardi and P.J.O. Van Nuffel, acting as Agents,

interveners,

THE COURT (Grand Chamber),

composed of K. Lenaerts, President, A. Arabadjiev, K. Jürimäe, C. Lycourgos, E. Regan, S. Rodin, I. Jarukaitis, N. Jääskinen and J. Passer, Presidents of Chambers, J.‐C. Bonichot, M. Safjan, F. Biltgen, P.G. Xuereb, A. Kumin and N. Wahl (Rapporteur), Judges,

Advocate General: M. Bobek,

Registrar: R. Şereş, Administrator,

having regard to the written procedure and further to the hearing on 8 June 2021,

after hearing the Opinion of the Advocate General at the sitting on 6 October 2021,

gives the following

**Judgment**

1        By their applications, the Italian Republic (C‐106/19) and the Comune di Milano (Municipality of Milan, Italy) (C‐232/19) seek the annulment of Regulation (EU) 2018/1718 of the European Parliament and of the Council of 14 November 2018 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (OJ 2018 L 291, p. 3; ‘the contested regulation’).

**Legal context**

2        On 12 December 1992, the Representatives of the Governments of the Member States adopted by common agreement, on the basis of Article 216 of the EEC Treaty, Article 77 of the ECSC Treaty and Article 189 of the EAEC Treaty, a decision on the location of the seats of the institutions and of certain bodies and departments of the European Communities (OJ 1992 C 341, p. 1; ‘the Edinburgh Decision’).

3        Article 1 of the Edinburgh Decision fixed the respective seats of the European Parliament, the Council of the European Union, the European Commission, the Court of Justice of the European Union, the European Economic and Social Committee, the European Court of Auditors and the European Investment Bank.

4        Under Article 2 of that decision:

‘The seat of other bodies and departments set up or to be set up will be decided by common agreement between the Representatives of the Governments of the Member States at a forthcoming European Council, taking account of the advantages of the above provisions to the Member States concerned, and giving appropriate priority to Member States who do not at present provide the sites for Community institutions.’

5        Article 341 TFEU provides that ‘the seat of the institutions of the Union shall be determined by common accord of the governments of the Member States’.

6        As provided in Protocol No 6 on the location of the seats of the institutions and of certain bodies, offices, agencies and departments of the European Union (‘Protocol No 6’), annexed to the EU, FEU and EAEC Treaties:

‘The Representatives of the Governments of the Member States,

Having regard to Article 341 of the Treaty on the Functioning of the European Union and Article 189 of the Treaty establishing the European Atomic Energy Community,

Recalling and confirming the Decision of 8 April 1965, and without prejudice to the decisions concerning the seat of future institutions, bodies, offices, agencies and departments,

Have agreed upon the following provisions ...:

*Sole Article*

(a)      The European Parliament shall have its seat in Strasbourg ...

(b)      The Council shall have its seat in Brussels. ...

(c)      The Commission shall have its seat in Brussels. ...

(d)      The Court of Justice of the European Union shall have its seat in Luxembourg.

(e)      The Court of Auditors shall have its seat in Luxembourg.

(f)      The Economic and Social Committee shall have its seat in Brussels.

(g)      The Committee of the Regions shall have its seat in Brussels.

(h)      The European Investment Bank shall have its seat in Luxembourg.

(i)      The European Central Bank shall have its seat in Frankfurt.

(j)      The European Police Office (Europol) shall have its seat in The Hague.’

**Background to the dispute**

7        The European Agency for the Evaluation of Medicinal Products was created by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1). That regulation contained no provision relating to the location of the seat of that agency.

8        Pursuant to Article 1(e) of Decision 93/C 323/01 of 29 October 1993, taken by common agreement between the Representatives of the Governments of the Member States, meeting at Head of State or Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol (OJ 1993 C 323, p. 1), that agency’s seat was located in London (United Kingdom).

9        Regulation No 2309/93 was repealed and replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1). By that regulation, the European Agency for the Evaluation of Medicinal Products was renamed ‘the European Medicines Agency’. That regulation contained no provision relating to the location of the seat of that agency.

10      On 29 March 2017, the United Kingdom of Great Britain and Northern Ireland notified the European Council, in accordance with Article 50(2) TEU, of its intention to withdraw from the European Union.

11      On 22 June 2017, in the margins of a meeting of the European Council relating to the procedure laid down in Article 50 TEU, the Heads of State or Government of the 27 other Member States approved, on the basis of a proposal from the President of the European Council and the President of the Commission, a procedure for the adoption of a decision on the transfer to other sites of the seats of the EMA and the European Banking Authority in the context of the United Kingdom’s withdrawal from the European Union (‘the selection rules’).

12      The selection rules provided, inter alia, that that decision was to be taken on the basis of a fair and transparent decision-making process, including the organisation of a call for offers based on precise objective criteria.

13      In that respect, six criteria were laid down in paragraph 3 of the selection rules, namely (i) the assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the European Union; (ii) the accessibility of the proposed location; (iii) the existence of adequate education facilities for the children of agency staff; (iv) appropriate access to the labour market, social security and medical care for both children and spouses; (v) business continuity, and (vi) geographical spread.

14      According to the selection rules, those criteria were established by analogy with those set out in the Common Approach set out in the annex to the Joint Declaration of the European Parliament, the Council and the Commission of 19 July 2012 on decentralised agencies (‘the 2012 Joint Declaration’), particular attention being paid to the fact that the EMA and the European Banking Authority had already been established and that the continuity of their activities was of paramount importance.

15      Paragraph 2 of the selection rules also provided that the decision would be taken by a voting process the outcome of which the Member States agreed in advance to respect. In particular, it was stated that, in case of a tie between the remaining offers in the third round of votes, the decision would be taken by drawing lots between the tied offers.

16      On 30 September 2017, the Commission published its assessment of the 27 offers submitted by the Member States.

17      On 31 October 2017, the Council published a note intended to supplement the selection rules on practical questions regarding voting.

18      On 20 November 2017, the Italian Republic’s offer and that of the Kingdom of the Netherlands obtained, *ex aequo*, the highest number of votes in the third round. After the drawing of lots organised in accordance with paragraph 2 of the selection rules, the Kingdom of the Netherlands’s offer was accepted.

19      Consequently, on the same date, the Representatives of the Governments of the Member States designated, in the margins of a meeting of the Council, the city of Amsterdam as the new seat of the EMA (‘the decision of 20 November 2017’). The minutes and press release of that meeting stated as follows:

‘The Commission will now prepare legislative proposals reflecting today’s vote for adoption under the ordinary legislative procedure with the involvement of the European Parliament. The Council and the Commission are committed to ensuring that those legislative proposals are processed as quickly as possible in view of the urgency of the matter.’

20      On 29 November 2017, the Commission adopted the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM(2017) 735 final). The reasons for that proposal stated that ‘in the context of the United Kingdom’s notification on 29 March 2017 of its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union, the 27 other Member States, meeting in the margins of the General Affairs Council (“Article 50”), [had] selected Amsterdam, the Netherlands, as the new seat of the [EMA]’. Article 1 of that proposal provided for the insertion of an Article 71a in Regulation No 726/2004, worded as follows: ‘The [EMA] shall have its seat in Amsterdam, the Netherlands.’

21      On 14 November 2018, the contested regulation was adopted on the basis of Article 114 and Article 168(4)(c) TFEU.

22      As provided in recitals 1, 2 and 3 of that regulation:

‘(1)      In the context of the United Kingdom’s notification on 29 March 2017 of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (“TEU”), the other 27 Member States, meeting on 20 November 2017 in the margins of the Council, selected Amsterdam, the Netherlands, as the new seat of the [EMA].

(2)      Having regard to Article 50(3) TEU, the [EMA] should take its new seat as of 30 March 2019.

(3)      To ensure the proper functioning of the [EMA] in its new location, a headquarters agreement should be concluded between the [EMA] and the Netherlands before the [EMA] takes up its new seat.’

23      Article 1 of the contested regulation inserted Article 71a into Regulation No 726/2004, worded as follows:

‘The [EMA] shall have its seat in Amsterdam, the Netherlands.

The competent authorities of the Netherlands shall take all necessary measures to ensure that the [EMA] is able to move to its temporary location no later than 1 January 2019 and that it is able to move to its permanent location no later than 16 November 2019.

The competent authorities of the Netherlands shall submit a written report to the European Parliament and the Council on the progress on the adaptations to the temporary premises and on the construction of the permanent building by 17 February 2019, and every three months thereafter, until the [EMA] has moved to its permanent location.’

24      Pursuant to the first and second paragraphs of Article 2 thereof, the contested regulation entered into force on the day of its publication in the *Official Journal of the European Union* and became applicable from 30 March 2019.

**Submissions of the parties**

***Case C***‐***106/19***

25      The Italian Republic claims that the Court should:

–        annul the contested regulation and

–        order the Council and the Parliament to pay the costs.

26      The Council contends that the Court should:

–        dismiss the action as unfounded and

–        order the Italian Republic to pay the costs.

27      The Parliament contends that the Court should:

–        dismiss the action, and

–        order the Italian Republic to pay the costs.

***Case C***‐***232/19***

28      The Comune di Milano claims that the Court should:

–        annul the contested regulation;

–        declare the decision of 20 November 2017 without legal effects, and

–        order the Council and the Parliament to pay the costs.

29      The Council contends that the Court should:

–        dismiss the action as inadmissible;

–        dismiss the action as unfounded, and

–        order the Comune di Milano to pay the costs.

30      The Parliament contends that the Court should:

–        dismiss the action as inadmissible or, in any event, as unfounded, and

–        order the Comune di Milano to pay the costs.

31      By document lodged at the Court Registry on 29 April 2019, the Parliament raised a plea of inadmissibility pursuant to Article 151(1) of the Rules of Procedure of the Court of Justice.

32      In its observations lodged at the Court Registry on 1 July 2019, the Comune di Milano contended, primarily, that the plea of inadmissibility should be rejected and, in the alternative, that that plea should be reserved until the ruling on the substance of the case.

**Procedure before the Court**

33      By decisions of the President of the Court of 20 May 2019 and 14 June 2019 in Cases C‐106/19 and C‐232/19, the Kingdom of the Netherlands and the Commission, respectively, were granted leave to intervene in support of the forms of order sought by the Council and the Parliament.

34      By decision of 26 November 2019, the plea of inadmissibility raised by the Parliament in Case C‐232/19 was reserved until the ruling on the substance of the case.

35      By decision of the President of the Court of 19 December 2019, Cases C‐106/19 and C‐232/19 were joined for the purposes of the procedure and the judgment.

36      On 19 November 2020, the Parliament, pursuant to the third paragraph of Article 16 of the Statute of the Court of Justice of the European Union, requested that the Court sit as a Grand Chamber in the present cases.

**The request for an expedited procedure**

37      By separate document of 11 February 2019, the Italian Republic requested that Case C‐106/19 be determined pursuant to the expedited procedure provided for in Article 133 of the Rules of Procedure. In support of that request, it submitted that the provisional transfer of the seat of the EMA to Amsterdam was ongoing at the date on which its application was lodged and that the definitive transfer of that seat was planned for November 2019, which gave rise to a particular urgency in dealing with that case.

38      Article 133(1) of the Rules of Procedure provides that, at the request of the applicant or the defendant, the President of the Court may, after hearing the other party, the Judge-Rapporteur and the Advocate General, decide that a case is to be determined pursuant to an expedited procedure where the nature of the case requires that it be dealt with within a short time.

39      In the present case, on 15 February 2021, the President of the Court decided, after hearing the other parties, the Judge-Rapporteur and the Advocate General, not to grant that request.

40      The granting of that request would not have enabled the Italian Republic to obtain suspension of the ongoing implementation of the contested regulation and, in particular, the process of transferring the seat of the EMA from London to Amsterdam. Moreover, the sensitive and complex nature of the legal problems raised by Case C‐106/19 and the related cases to which the Italian Republic referred in its application did not lend themselves easily to the application of such a procedure, since, in particular, it did not appear appropriate to shorten the written part of the procedure before the Court (see, by analogy, judgment of 18 May 2021, *Asociația ‘Forumul Judecătorilor din România’ and Others*, C‐83/19, C‐127/19, C‐195/19, C‐291/19, C‐355/19 and C‐397/19, EU:C:2021:393, paragraph 103 and the case-law cited).

**The actions**

***Admissibility of the action brought by the Comune di Milano in Case C***‐***232/19***

*Arguments of the parties*

41      The Council submits that the action in Case C‐232/19 is manifestly inadmissible, since the Comune di Milano has neither *locus standi* nor a legal interest in bringing proceedings against the contested regulation.

42      As regards, in the first place, *locus standi*, the Council submits that the Comune di Milano is not directly and individually concerned by the contested regulation, which is a legislative act, within the meaning of Article 289(3) TFEU, adopted under the ordinary legislative procedure provided for in Article 294 TFEU.

43      First, as regards the question whether the Comune di Milano is directly concerned by the contested regulation, the Council considers that the Comune di Milano does not demonstrate what harmful material effects it suffered following the adoption of that regulation. The fact that the Comune di Milano was chosen by the Italian Republic in the context of its bid to host the seat of the EMA does not make it a person directly concerned by that regulation.

44      Secondly, as regards whether the Comune di Milano is individually concerned by the contested regulation, the Council claims that the Comune di Milano has failed to demonstrate how the adoption of that regulation adversely affected the specific exercise of its powers, as defined in the Italian legal order. Furthermore, since the Comune di Milano was not involved in the procedure for the adoption of that regulation, the fact that it participated in the preparation of the Italian offer and the selection procedure does not prove that it is individually concerned by that regulation.

45      In that regard, the Council notes that EU law does not confer, either in the procedural rules or in acts intended for the selection of the seat of the EMA, any specific right of participation on persons other than the Member States. The case-law cited by the Comune di Milano, which acknowledges that individuals have *locus standi* where they are expressly referred to in the preparatory documents for the contested measures and those measures stem from the specific taking into consideration of matters concerning those individuals, is irrelevant. Similarly, the Comune di Milano has not shown what specific circumstances characterise its legal situation in such a way that it may be regarded as an addressee of the contested regulation. Furthermore, the Council states that the reference to principles identified in the field of public procurement is irrelevant. Lastly, the alleged expenditure incurred by the Comune di Milano, which was incurred on its own initiative, does not show that it is individually concerned by that regulation.

46      As regards, in the second place, the legal interest in bringing proceedings, the Council takes the view that the Comune di Milano has not proved that it has a personal, vested and present interest in the action brought. First of all, the sole consequence if that action were to succeed would be the annulment of the measure incorporating the decision taken by the Member States to locate the seat of the EMA in Amsterdam, and not the designation as such of the city of Milan as the new seat of that agency. Next, the possibility that that action may succeed is not sufficient to ensure that the conditions for obtaining damages are satisfied. Lastly, any economic or social consequences arising from the adoption of an EU measure do not, as such, make it possible to establish that a local authority is individually concerned by that measure. A local authority’s interest in bringing proceedings exists only where the contested decision is likely to have a beneficial effect on its legal situation, that is to say, where that decision has consequences for the exercise of the powers conferred on it by national law.

47      The Parliament also submits that the Comune di Milano does not have *locus standi* or even a legal interest in bringing proceedings against the contested regulation. It states in particular that, since that regulation is a legislative act of the European Union within the meaning of Article 289(3) TFEU, it is for the Comune di Milano to show that it is directly and individually concerned by it. However, that is clearly not demonstrated in the present case.

48      In the first place, as regards *locus standi*, the Parliament submits, first, that the circumstances relied on by the Comune di Milano do not demonstrate that the contested regulation, which merely locates the new seat of the EMA in Amsterdam, is of direct concern to it. That regulation, in essence, merely establishes the new seat of the EMA following the proposal made by the Commission. At no time did the EU legislature receive a proposal to locate that seat in Milan. In the absence of any legal connection between the choice made in the decision of 20 November 2017 and the Commission’s proposal for that regulation, it is not permissible to take the view that the Comune di Milano is directly concerned by the provisions of that regulation.

49      Secondly, the Parliament submits that the Comune di Milano is also not individually concerned by the contested regulation, since the circumstances on which that local authority relies are not sufficient to establish that it is in a situation which differentiates it from all other persons within the meaning of the Court’s case-law. In particular, any possible involvement of the Comune di Milano in respect of the cooperation between Member States to determine the location of the new seat of the EMA, in particular under the selection rules approved on 22 June 2017, could not have the effect of differentiating the city of Milan in such a way as to satisfy the condition of individual concern referred to in the fourth paragraph of Article 263 TFEU. Furthermore, and irrespective of the value to be given to those rules, they do not confer any particular role on local authorities in the selection of the offers submitted, that role being reserved to the governments of the Member States concerned. On that point, the situation in the present case differs from that at issue in the fields of anti-dumping duties and public procurement, where the participation of certain operators is expressly provided for by the legislation in force.

50      In the second place, as regards the Comune di Milano’s legal interest in bringing proceedings, the Parliament takes the view that the arguments put forward by the Comune di Milano do not substantiate to the requisite legal standard the existence of such a genuine personal interest. First of all, it is difficult to conceive that any annulment of the contested regulation would be capable of procuring an advantage for it, within the meaning of the relevant case-law, in the absence of any direct effect of that regulation on the legal situation of the Comune di Milano. Next, the Parliament submits that, in any event, the interest relied on by the Comune di Milano cannot be equated to a ‘personal’ interest. It is clear that that regulation does not interfere in any way with the legislative or financial autonomy of the Comune di Milano since it merely locates the new seat of the EMA in Amsterdam. In that regard, the Parliament submits that it is the Italian Government and not the Comune di Milano which took part in the selection procedure. Furthermore, even if the contested regulation were to be annulled, the transfer of the seat of the EMA to Milan would be purely hypothetical and could not therefore be relied on as a basis for the Comune di Milano’s legal interest in bringing proceedings. Lastly, the Parliament argues that a possible annulment of that regulation cannot be capable of restoring a situation which the regulation has not changed.

51      The Comune di Milano, for its part, submits that it has established not only standing to seek annulment of the contested regulation, but also a legal interest in bringing proceedings.

52      As regards, specifically, its *locus standi*, the Comune di Milano points out that the contested regulation, which produces effects *erga omnes* and which is directly applicable, undeniably affects its legal situation in its capacity as candidate city and active participant in the process of designating the new seat of the EMA. It submits that, as has been held in the field of anti-dumping duties or concerning public procurement, persons who have been identified or who have participated in a procedure which led to the adoption of an act have specific standing to bring proceedings against that act. It points out that, during the selection procedure at issue in the present case, the outcome of which determined the content of the contested regulation, the city of Milan obtained the highest number of votes and that, since its candidature satisfied all the necessary requirements, the only reason why it was not designated as the new seat of the EMA lies in the unlawfulness of that regulation.

*Findings of the Court*

53      It should be noted at the outset that an action brought by a regional or local entity cannot be treated in the same way as an action brought by a Member State, the term Member State within the meaning of Article 263 TFEU referring only to government authorities of the Member States (judgment of 13 January 2022, *Germany and Others* v *Commission*, C‐177/19 P to C‐179/19 P, EU:C:2022:10, paragraph 69 and the case-law cited).

54      Like any natural or legal person referred to in the fourth paragraph of Article 263 TFEU, such entities are subject to the specific conditions laid down by that provision. They must therefore establish, separately and cumulatively, both an interest in bringing proceedings and *locus standi* against the act the annulment of which they seek (see, to that effect, judgment of 17 September 2015, *Mory and Others* v *Commission*, C‐33/14 P, EU:C:2015:609, paragraph 62 and the case-law cited).

–       *The Comune di Milano’s legal interest in bringing proceedings*

55      According to the Court’s settled case-law, an action for annulment brought by a natural or legal person is admissible only in so far as that person has an interest in having the contested act annulled. Such an interest requires that the annulment of that act must be capable, in itself, of having legal consequences and that the action may therefore, through its outcome, procure an advantage to the party that brought it. The proof of such an interest, which is evaluated at the date on which the action is brought and which is an essential and fundamental prerequisite for any legal proceedings, must be adduced by the applicant (judgments of 18 October 2018, *Gul Ahmed Textile Mills* v *Council*, C‐100/17 P, EU:C:2018:842, paragraph 37, and of 27 March 2019, *Canadian Solar Emea and Others* v *Council*, C‐236/17 P, EU:C:2019:258, paragraph 91).

56      In the present case, any annulment of the contested regulation could lead to the adoption of a new regulation which is substantively different from the contested regulation. As the Comune di Milano submits, such an annulment would entail the resumption of the legislative procedure to determine the location of the seat of the EMA, with the possible consequence that the city of Milan is proposed and chosen to host that seat, and that, at the end of the new selection procedure, that city is designated as the new location of that agency.

57      It follows that the Comune di Milano has shown an interest in seeking the annulment of the contested regulation.

–       Locus standi *of the Comune di Milano*

58      In accordance with the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

59      In that regard, a regional or local entity may, in so far as, like the Comune di Milano, it has legal personality under national law, bring an action for annulment under the fourth paragraph of Article 263 TFEU (judgment of 22 June 2021, *Venezuela* v *Council (Whether a third state is affected)*, C‐872/19 P, EU:C:2021:507, paragraph 45 and the case-law cited).

60      In the present case, it is important to note that the contested regulation must be classified as a legislative act since it was adopted both on the basis of Article 114 TFEU and Article 168(4)(c) TFEU, and in accordance with the ordinary legislative procedure. In those circumstances, it is only if the Comune di Milano can be regarded as being directly and individually concerned by that regulation that its action is admissible.

61      In the first place, concerning whether the Commune di Milano is directly concerned by the contested regulation, it should be noted that the requirement laid down in the fourth paragraph of Article 263 TFEU, that a natural or legal person must be directly concerned by the measure forming the subject matter of the proceedings requires the fulfilment of two cumulative criteria, namely the contested measure should, first, directly affect the legal situation of the individual and, secondly, leave no discretion to the addressees who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from EU rules alone without the application of other intermediate rules (see, to that effect, judgments of 6 November 2018, *Scuola Elementare Maria Montessori* v *Commission*, *Commission* v *Scuola Elementare Maria Montessori* and *Commission* v *Ferracci*, C‐622/16 P to C‐624/16 P, EU:C:2018:873, paragraph 42, and of 22 June 2021, *Venezuela* v *Council* *(Whether a third state is affected)*, C‐872/19 P, EU:C:2021:507, paragraph 61 and the case-law cited).

62      It is necessary to examine in turn whether the Comune di Milano satisfies each of those two requirements.

63      First, the contested regulation designates the city of Amsterdam as the seat of the EMA with immediate and binding effect. Since that regulation leaves no discretion as to the designation of the location of the seat of the EMA and that, in that regard, it has legal effect without any additional measure being required, the second requirement, referred to in paragraph 61 of the present judgment, is satisfied.

64      As the Advocate General observed, in essence, in point 97 of his Opinion, that finding is not called into question by the fact that, according to recital 3 to the contested regulation, the specific rights and obligations of the city of Amsterdam are intended to be specified in a Seat Agreement to be concluded between the EMA and the Kingdom of the Netherlands.

65      Secondly, as regards whether the contested regulation directly affects the applicant’s legal situation, it should be noted that the city of Milan, represented by the Comune di Milano, as a territorial entity with legal personality, was one of the candidate cities for the purposes of establishing the location of the new seat of the EMA.

66      Moreover, it is common ground that the bid of the City of Milan was expressly examined during the legislative procedure and that the Commission’s proposal referred to in paragraph 20 of this judgment was the subject of several proposed amendments in the procedure before the Parliament.

67      In those circumstances, the legal situation of the Comune di Milano was directly affected by the adoption of the contested regulation, in so far as it designated, in a legally binding manner, the city of Amsterdam as the location of the new seat of the EMA, with the automatic effect that Milan, a candidate city, was excluded as the location of that new seat.

68      In the second place, as regards whether the Comune di Milano is individually concerned by the contested regulation, it is settled case-law that, in order to be individually concerned by a measure of general application, a person who brings an action for annulment must show that the contested measure affects that person by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of these factors distinguishes them individually just as in the case of the person addressed (see, to that effect, judgments of 15 July 1963, *Plaumann* v *Commission*, 25/62, EU:C:1963:17, p. 107, and of 20 January 2022, *Deutsche Lufthansa* v *Commission*, C‐594/19 P, EU:C:2022:40, paragraph 31 and the case-law cited).

69      In the present case, it should be noted, first, that, as provided in recital 1 of the contested regulation, the adoption of that regulation followed the selection procedure which led to the adoption of the decision of 20 November 2017.

70      It is common ground that, in the context of that selection procedure, the city of Milan was designated by the Italian Republic as the candidate city to host the new seat of the EMA and that, following the third ballot, it obtained, *ex aequo* with the city of Amsterdam, its direct competitor, the highest number of votes. Therefore, the city of Milan was part of the closed class of candidate cities for hosting that seat, and was therefore, at the time when the contested regulation was adopted, in a special situation with regard to the latter so as to confer on it the right to effective judicial protection.

71      Secondly, as the Council itself pointed out in its written pleadings, the location of the city of Milan was expressly referred to, on several occasions, as a possible seat of the EMA, during the legislative procedure leading to the adoption of the contested regulation.

72      Thus, the Comune di Milano is, in the circumstances of the present case, in a factual situation which distinguishes it individually just as in the case of the person to whom a measure is addressed.

73      That conclusion is not called into question by the fact that the selection procedure conducted prior to the adoption of the contested regulation conferred a role only on the Member States and not on local authorities. It is apparent from the file submitted to the Court that the Comune di Milano was closely involved in the drawing-up of the offer formally submitted by the Italian Republic and in the administrative steps to promote the city of Milan for the purpose of designating the new seat of the EMA.

74      Nor is that conclusion affected by the case-law, reflected, in particular, in paragraph 73 of the judgment of 13 January 2022, *Germany and Others* v *Commission* (C‐177/19 P to C‐179/19 P, EU:C:2022:10), relating to the particular situation, different from that at issue in the present case, in which an infra-State body claims that the act whose annulment it seeks prevents it from exercising, as it sees fit, the powers conferred on it by the national constitutional order.

75      Indeed, as the Parliament and the Council have pointed out, it is not sufficient, in order to recognise the admissibility of an action brought by a regional or local authority of a Member State, for that authority to rely on the fact that the application or implementation of an EU act is likely to have a general effect on socio-economic conditions in its territory.

76      However, the action brought by the Comune di Milano relates to a different situation, namely that in which a city was designated as the seat of an agency of the Union, with the result that applications from other cities, including the city of Milan, were rejected, since the designation decision had the effect of determining the favourable or unfavourable outcome of all the applications.

77      It follows from all the foregoing that, irrespective of the autonomous right of action available to the Italian Republic under the second paragraph of Article 263 TFEU, the Comune di Milano is directly and individually concerned by the contested regulation and, therefore, has standing to seek its annulment.

78      It follows that the action brought in Case C‐232/19 is admissible.

***Substance***

79      In support of its action in Case C‐106/19, the Italian Republic relies on two pleas in law. The first plea alleges, in essence, infringement of Articles 10, 13 and 14 TEU and of Article 114, Article 168(4)(c) and Articles 289 and 294 TFEU, in that the Parliament did not fully exercise its legislative prerogatives. The second plea alleges that the decision of 20 November 2017 is unlawful as a basis for the contested regulation.

80      The Comune di Milano, for its part, puts forward four pleas in support of its action in Case C‐232/19. The first plea, which is specifically directed against the contested regulation, alleges infringement of the principles of representative democracy (Article 10 TEU), institutional balance and sincere cooperation (Article 13 TEU) and essential procedural requirements (Article 14 TEU and Articles 289 and 294 TFEU). The second to fourth pleas, which call into question, by way of objection, the lawfulness of the decision of 20 November 2017 on which that regulation is based, allege, respectively, misuse of powers and infringement of the principles of transparency, sound administration and fairness (second plea), infringement of the principles of sound administration, transparency and cooperation (third plea), and infringement of Council Decision 2009/937/EU of 1 December 2009 adopting the Council’s Rules of Procedure (OJ 2009 L 325, p. 35) and the rules set out in the Council’s note of 31 October 2017.

*The first plea in Case C*‐*106/19 and the first plea in Case C*‐*232/19*

–       *Arguments of the parties*

81      By its first plea in Case C‐106/19, the Italian Republic claims that the contested regulation was adopted in breach of Articles 10 and 13 TEU, Article 14(1) TEU, Article 114 TFEU, Article 168(4)(c) TFEU and Articles 289 and 294 TFEU, in so far as the Parliament’s role as co-legislator was ignored.

82      As a preliminary point, the Italian Republic states that, in view of the development of EU law and institutional practice, the designation of the seat of EU agencies does not fall within the competence of the Member States, as is the case for determining the seat of the institutions of the Union under Article 341 TFEU, but within the competence of the European Union.

83      According to the Italian Republic, the Parliament played only a purely formal role in the decision-making process leading to the choice of the new seat of the EMA and the adoption of the contested regulation. That is evidenced by the circumstances surrounding the adoption of that regulation, in particular the Parliament’s statements annexed to its position adopted at first reading on 15 March 2018 and to its legislative resolution of 25 October 2018, by which the Parliament clearly indicated its regret that it had been removed from that decision-making process. The Parliament was also not in a position to express its views on that choice nor, therefore, to exercise its prerogatives as co-legislator, whether during the stage which led to the adoption of the decision of 20 November 2017 or during the procedure for the adoption of the contested regulation, since the Commission’s proposal and the position adopted by the Council during that procedure left it no actual scope to intervene.

84      By its first plea in Case C‐232/19, the Comune di Milano submits that the contested regulation was adopted in breach of the Parliament’s prerogatives. There is no doubt that the seat of the EMA was chosen at the end of the process which led to the decision of 20 November 2017, which determined the content of that regulation and therefore the location of the seat of the EMA in Amsterdam, outside the ordinary legislative procedure. The Parliament was at no time involved in that process, even though, under Article 294 TFEU, the ordinary legislative procedure involves its full and effective participation. The Council and the Commission decided to choose the city of Amsterdam as the new seat of the EMA and thus presented the Parliament with a fait accompli without giving it any scope to intervene in order to challenge that decision.

85      That resulted in an infringement of the institutional balance of the European Union and of the principles of representative democracy and sincere cooperation (judgment of 21 June 2018, *Poland* v *Parliament and Council*, C‐5/16, EU:C:2018:483, paragraph 90) and an infringement of an essential procedural requirement (judgment of 6 September 2017, *Slovakia and Hungary* v *Council*, C‐643/15 and C‐647/15, EU:C:2017:631, paragraph 160).

86      That the infringement of the Parliament’s prerogatives during the legislative process led to the designation of the city of Amsterdam as the new seat of the EMA is clear from the statements made by that institution and from the amendments proposed by it at the first reading.

87      The Council, supported by the Kingdom of the Netherlands, contends that the first plea in Case C‐106/19 and the first plea in Case C‐232/19 should be rejected.

88      In the first place, it submits that the examination of the legislative process followed in the present case clearly shows, as is demonstrated in particular by the number of proposed amendments on the draft legislative resolution, that the Parliament fully discussed the proposal submitted by the Commission and examined the various possible options, before accepting that the seat of the EMA should be located in Amsterdam. The Parliament also ensured that a number of relevant amendments were incorporated into the final legislative text. Those circumstances demonstrate that, from a factual point of view, and leaving aside any policy statement, the Parliament’s prerogatives were respected.

89      As regards the argument based on statements made by the Parliament, the Council points out that the intention of an institution is reflected by the measures which it is for it to adopt in compliance with the applicable formal procedures. In those circumstances, although the explanatory statements which sometimes accompany that formal process may provide evidence of a political context or set out the political reasons underlying a given decision, they are in themselves irrelevant for the purposes of assessing the actual exercise of a competence.

90      In the second place, the Council considers that competence to determine the seat of an agency of the Union lies with the representatives of the governments of the Member States acting by common accord. Therefore, the designation of the seat of the EMA in the contested regulation is merely declaratory, and the co-legislator could not have departed from it, while remaining free not to legislate on that point.

91      In that regard, the Council submits, first, that competence to determine the location of the seat of an agency of the Union does not fall within the competence that the European Union has to govern a specific substantive area and, therefore, in the present case, the ordinary legislative procedure. According to the Council, the decision on the location of the seat of an agency is fundamentally different in nature from decisions governing the definition of competencies, the operating rules, or even the organisation of that agency. Such a decision is characterised by a strong political and symbolic dimension, which is not limited to the specific material field of the agency in question and which goes beyond mere considerations of economy or efficiency. The Council refers, in that regard, to the various intergovernmental statements on the subject, in particular to the Edinburgh Decision, but also to disputes concerning the seat of the Parliament.

92      Secondly, the Council is of the opinion that Article 341 TFEU provides the basis for the competence of the Member States to determine the location of the seat of an agency of the Union by common accord. It follows from an analysis of the historical development of that provision and its context that the reference to ‘institutions’ must not be interpreted restrictively, as referring only to the institutions referred to in Article 13(1) TEU. That interpretation corresponds, moreover, to the established practice in that area, a practice which, as is shown by Article 2 of the Edinburgh Decision and the 2012 Joint Declaration, was given interinstitutional recognition. That practice clearly shows, in particular, that, far from being purely political, a decision taken by the Representatives of the Governments of the Member States by common accord is legally binding to the point of becoming, in certain cases, a condition for the entry into force of the basic act.

93      According to the Council, the nature of the European Union’s competence in a given area should not be confused with the detailed rules by which it is to be exercised in accordance with the Treaties. Thus, a competence could be exclusive because it is linked to a matter which necessarily requires action at EU level, but provision could be made at the same time for it to be exercised by means of a decision of the Representatives of the Governments of the Member States rather than the institutions of the Union. That would be the case, for example, with the appointment of Judges and Advocates General of the Court of Justice under Article 253 TFEU and that of the Members of the General Court under Article 254 TFEU.

94      Lastly, the Council states that the fact that the co-legislators are required to follow the choice made by the Member States does not mean that the inclusion, in the basic legislative act, of the location of the seat of the agency of the Union concerned has no added value. Apart from the fact that that indication is an important factor contributing to legal certainty, the legislative text could, as in the present case with the insertion of Article 71a into Regulation No 726/2004 by Regulation 2018/1718, include in that indication a series of other legislative elements, both substantive and procedural, in order to supplement the purely geographical location of the seat. That is the case here, since Article 71a not only states that the seat of the EMA is in Amsterdam, but also requires the competent Netherlands authorities, first, to take all necessary measures to ensure that the EMA is able to move to its temporary location and then its permanent location before specific dates and, secondly, to submit written reports on a regular basis to the Parliament and the Council until the EMA has moved to its permanent location. Such additional binding effects thus derive directly and exclusively from the contested regulation, for the adoption of which the Parliament fully exercised its prerogatives as co-legislator, and not from the choice of seat made by the Representatives of the Governments of the Member States.

95      The Parliament also contends that the first plea in Case C‐106/19 and the first plea in Case C‐232/19 should be rejected, but for reasons different from those put forward by the Council.

96      As a preliminary point, the Parliament states that it fully agrees with the applicants’ conclusion that an act such as the decision of 20 November 2017 cannot in any way legitimately restrict the exercise of the powers conferred on the EU legislature by the Treaties. However, contrary to the submissions of those parties, the Parliament considers that the defects liable to affect that decision cannot render the contested regulation unlawful, directly or indirectly.

97      The Parliament submits, in essence, that, in so far as the Representatives of the Governments of the Member States have no power to determine the location of the seat of the bodies of the Union, the decision of 20 November 2017 cannot be given any binding effect, capable of limiting the EU legislature’s discretion to intervene. To accept the contrary would amount to legitimising the existence of a decision-making process unrelated to the institutional architecture conceived by the Treaties, which does not confer on the Member States competence to determine the seat of the institutions or bodies of the Union, in particular its agencies. Nor can such a reservation of competence be inferred from Article 341 TFEU, which refers exclusively to the ‘institutions of the Union’ laid down by Article 13(1) TEU. In view of the fact, moreover, that the institutions of the Union cannot voluntarily relinquish the exercise of the powers conferred on them by the Treaties, the Commission could not, for its part, act in its proposal for a regulation without reserving the choice made by the Representatives of the Governments of the Member States in the decision of 20 November 2017, without itself carrying out a discretionary assessment, just as the co-legislators could not give a legally binding assurance that they would adopt such a proposal. It follows that the agreements successively concluded between the Member States concerning, first of all, the selection rules adopted on 22 June 2017 and, subsequently, the choice of the city of Amsterdam as the new seat of the EMA under the decision of 20 November 2017, constitute acts of purely political cooperation which cannot limit the powers of the institutions of the Union.

98      The Parliament states that it has in no way waived the exercise of the legislative prerogatives conferred on it by the Treaties. It points out that the possible political impact of the position of the Member States on a decision-making procedure laid down by the Treaties, and in particular on the Commission’s power of legislative initiative and on the legislative power of the Parliament and the Council, cannot constitute a ground for annulment of the act adopted under that procedure.

99      In the present case, the Parliament took care to preserve its institutional position by all the means at its disposal, its main concern throughout the legislative procedure having been to ensure the continuity of the EMA’s activities, in order to prevent the proper performance of the important task of that EU agency concerning the protection of public health from being compromised by the transfer of its seat. It was with that aim that, on the Parliament’s initiative, a transfer timetable and a monitoring mechanism were laid down in the second and third paragraphs, respectively, of Article 71a of Regulation No 726/2004, as inserted by the contested regulation. That same concern is also reflected in recitals 3 to 5 of that regulation, which were also introduced during the legislative procedure.

100    Lastly, the Parliament states that, while it is true that the choice of the seat of a body, office or agency of the Union has particular political value for the Member States, that does not justify attributing to the Member States a power which is not conferred on them by the Treaties, such as that of making such a choice (see, to that effect, Opinion 2/00 *(Cartagena Protocol on Biosafety)*, of 6 December 2001, EU:C:2001:664, paragraph 22 and the case-law cited).

101    Thus, the initiative taken in the context of intergovernmental cooperation with a view to determining the location of the new seat of the EMA should be accorded only the value of cooperation of a strictly political nature, which led to the decision of 20 November 2017, which was also of a political nature and not legally binding. That decision is without prejudice to the powers conferred on the institutions of the Union in the context of the ordinary legislative procedure, which alone is applicable in the present case. In addition, and more importantly, the recommendation made by the Member States in the decision of 20 November 2017 and the prior selection process cannot be regarded as the preparatory stage of the legislative procedure which led to the adoption of the contested regulation. More generally, no distinction should be drawn between the legal value and the political effects of the decision of 20 November 2017.

102    The Parliament states that although, in the present case, it ultimately decided to approve the choice of the city of Amsterdam as the new seat of the EMA, it did so by exercising the discretion conferred on it in the context of its role as co-legislator, and not because it was forced to do so by the position of the Member States. Moreover, the Parliament’s statement, annexed to the legislative resolution of 25 October 2018, does not at any point recognise the legally binding nature of the decision of 20 November 2017.

103    The Commission, intervening in support of the forms of order sought by the Council and the Parliament, contends that the first pleas in law in Cases C‐106/19 and C‐232/19 should be rejected.

104    Like the Parliament, the Commission considers that the choice made by the Representatives of the Governments of the Member States could not impede either its power of initiative or the prerogatives of the two defendant institutions in their capacity as co-legislators. It explains that, while Article 341 TFEU undeniably inspired the practice followed to date when the various bodies, offices and agencies of the Union were established, and although the Commission has made use of its power of initiative as a whole by recognising the relevance of general policy considerations linked mainly to the need to ensure geographical balance in the determination of the location of different seats and by failing to provide for the location of the seat of agencies of the Union in the proposals for acts establishing them, it is nevertheless free to depart from that practice, as it has done in various circumstances, in particular by indicating in its legislative proposals the location of the seat of certain agencies of the Union. Thus, the Commission is not legally obliged to transpose the choice made by the Representatives of the Governments of the Member States or of certain Member States. Similarly, the Parliament was not, in any event, legally bound by the decision of the Representatives of the Governments of the Member States taken in accordance with that practice.

105    The Commission points out that a distinction must be drawn between the political impact of a position taken by the Member States and its legally binding force, which is lacking in the present case. That distinction is, according to the Commission, confirmed by the case-law according to which, first, it is exclusively for the Parliament and the Council to determine the content of a legislative act and, secondly, the existence of a political effect cannot be a ground for annulment of an act adopted at the end of the legislative procedure (judgment of 21 June 2018, *Poland* v *Parliament and Council*, C‐5/16, EU:C:2018:483, paragraphs 84 and 86 and the case-law cited).

106    The Commission adds that there is no reason to think that the co-legislator, which the Court has already recognised as being in a position to decide on the establishment of a body such as an agency of the Union (judgment of 2 May 2006, *United Kingdom* v *Parliament and Council*, C‐217/04, EU:C:2006:279, paragraphs 44 and 45), cannot, as was the case here, decide with complete independence on the location of the seat of that agency. The Commission notes that, during the debate before the Parliament on its proposal for the contested regulation, the designation of the city of Milan as the seat of the EMA was rejected after being the subject of specific discussion. That fact proves that the possibility of departing from the political decision of the Representatives of the Governments of the Member States is not purely theoretical and that, in the present case, the Parliament was not faced with a ‘fait accompli’.

–       *Findings of the Court*

107    By the first plea in Case C‐106/19 and the first plea in Case C‐232/19, which it is appropriate to examine together, the Italian Republic and the Comune di Milano submit, in essence, that the Parliament’s prerogatives were not respected during the process leading to the designation of the city of Amsterdam as the new seat of the EMA, in breach of the provisions of the Treaties, in particular Articles 10, 13 and 14 TEU, Article 114, Article 168(4)(c) and Articles 289 and 294 TFEU.

108    Examination of those pleas requires a ruling, as a preliminary point, on the question of who, Member States or the EU legislature, has the power to determine the location of the seat of a body, office or agency of the Union, which involves, in particular, determining whether Article 341 TFEU, under which the seat of the ‘institutions’ of the Union is to be determined ‘by common accord of the governments of the Member States’, also applies to the bodies, offices and agencies of the Union.

109    On the assumption that, as the Council maintains, it ought to be concluded that that competence is reserved to the Member States acting by common accord, the EU legislature cannot lawfully depart from the decision taken in that regard by the Member States, even if it remained free not to legislate on that point, and if the act which it would be prompted to adopt had only declaratory or confirmatory force.

110    On the other hand, if it were to be concluded that that competence belongs to the EU legislature by virtue of the powers conferred on it by the Treaties, it is necessary to assess whether, as the Italian Republic and the Comune di Milano submit, the decision of 20 November 2017 limited the prerogatives of the EU legislature and, more broadly, compromised the institutional balance in the procedure followed with a view to adopting the contested regulation.

(1)    *Competence to determine the location of the seat of the bodies, offices and agencies of the Union*

111    According to settled case-law of the Court, the interpretation of a provision of EU law requires that account be taken not only of its wording and the objectives it pursues, but also of its context. The origins of a provision of EU law may also provide information relevant to its interpretation (see, to that effect, judgment of 10 December 2018, *Wightman and Others*, C‐621/18, EU:C:2018:999, paragraph 47 and the case-law cited).

112    It is, therefore, necessary to examine, on the basis of those methods of interpretation, whether Article 341 TFEU applies to decisions determining the seat of the bodies, offices and agencies of the Union.

113    In the first place, as regards the wording of Article 341 TFEU, it refers only to the ‘institutions of the Union’. In accordance with Article 13(1) TEU, the concept of ‘institutions’ refers to a precise list of entities which does not include the bodies, offices and, in particular, the agencies of the Union.

114    In the second place, as regards the context of Article 341 TFEU, it must be pointed out, first of all, as observed by Advocate General Bobek in point 94 of his Opinion in *Italy* v *Council (Seat of the European Medicines Agency)* and *Parliament* v *Council (Seat of the European Labour Authority)* (C‐59/18, C‐182/18 and C‐743/19, EU:C:2021:812), that a number of provisions of the Treaties have been amended by the Treaty of Lisbon in order to include an express reference to the ‘bodies, offices and agencies of the Union’, which has had the effect of expressly distinguishing between, on the one hand, the institutions of the Union expressly referred to in Article 13(1) TEU and, on the other, the bodies, offices and agencies of the Union. Thus, while some provisions of the FEU Treaty refer only to the institutions of the Union, other provisions of the FEU Treaty, such as Articles 15, 16, 123, 124, 127, 130, 228, 263, 265, 267, 282, 298 and 325, refer, more broadly, to the institutions, bodies, offices and agencies of the Union. That is the case in particular, as regards the Court’s jurisdiction, with Articles 263, 265 and 267 TFEU.

115    It is clear that the wording of Article 341 TFEU, which refers only to the ‘institutions’, corresponds to that of the provisions which preceded that article, namely Article 216 of the EEC Treaty (subsequently Article 216 of the EC Treaty, which in turn became Article 289 EC).

116    The fact, put forward by the Council, that the provisions of Part Seven of the FEU Treaty, of which Article 341 TFEU forms part, entitled ‘General and Final Provisions’, refer to the ‘institutions’ cannot therefore be interpreted – even though, as is clear from paragraph 114 above, the EU Treaty draws a clear distinction between the institutions of the Union, on the one hand, and the bodies, offices and agencies of the Union, on the other – as an expression of the intention of the framers of the Treaties to confer a broad understanding on the concept of ‘institutions’, in that that concept would encompass not only the entities listed in Article 13(1) TEU, but also the bodies, offices and agencies of the Union established by or under the Treaties and intended to contribute to the achievement of the European Union’s objectives. This is all the more so since the EU Treaty and the TFEU constitute a unitary constitutional basis for the European Union by reason of the third paragraph of Article 1 TEU and Article 1(2) TFEU, with the result that the definition of the concept of ‘institutions’ in Article 13(1) TEU and the distinction between those institutions, on the one hand, and the bodies, offices and agencies of the Union, on the other, must apply transversely and uniformly in both treaties.

117    Nor can the broad interpretation given by the Court to the concept of ‘institutions’, within the meaning of the second paragraph of Article 340 TFEU, be determinative, that provision stating that ‘in the case of non-contractual liability, the Union shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its institutions or by its servants in the performance of their duties’.

118    Although the Court has held that the term ‘institutions’ within the meaning of that provision encompasses not only the institutions of the Union listed in Article 13(1) TEU but also all the bodies, offices and agencies of the Union that have been established by or under the Treaties and are intended to contribute to the achievement of the European Union’s objectives (judgment of 16 December 2020, *Council and Others* v *K. Chrysostomides & Co. and Others*, C‐597/18 P, C‐598/18 P, C‐603/18 P and C‐604/18 P, EU:C:2020:1028, paragraph 80 and the case-law cited), it expressly relied, in order to establish that case-law, on the fact, first, that the bodies, offices and agencies of the Union established by or under the Treaties are intended to contribute to the achievement of the European Union’s objectives and, secondly, that it would be contrary to the intention of the framers of the Treaties if, when it acts through a body, office or agency, the European Union could escape the consequences of the provisions of the Treaties governing the European Union’s non-contractual liability (see, to that effect, judgment of 2 December 1992, *SGEEM and Etroy* v *EIB*, C‐370/89, EU:C:1992:482, paragraphs 13 to 16).

119    Thus, the broad interpretation given by the Court to the concept of ‘institutions’, for the purposes of applying the second paragraph of Article 340 TFEU, meets the need, justified by the general principles common to the laws of the Member States expressly referred to in that provision, to prevent the European Union from being able to avoid the application of the system of non-contractual liability under Article 268 TFEU, read in conjunction with the second paragraph of Article 340 TFEU, and the resulting judicial review by the Court, where the European Union acts through a body, office or agency of the Union other than the institutions listed in Article 13(1) TEU (see, by analogy, judgment of 2 December 1992, *SGEEM and Etroy* v *EIB*, C‐370/89, EU:C:1992:482, paragraphs 14 and 16). This must all the more be so since, as the Advocate General stated in point 100 of his Opinion, the concept of ‘servants’ in the second paragraph of Article 340 TFEU encompasses from a functional point of view all the staff working for the European Union, whether in the institutions or in the bodies, offices and agencies of the Union.

120    Consequently, the interpretation given to the concept of ‘institutions’ within the meaning of the second paragraph of Article 340 TFEU, which governs the extent of the non-contractual liability of the European Union, cannot be properly relied upon for the purposes of defining by analogy the scope of Article 341 TFEU, relating to the extent of the powers reserved to the Member States under the Treaties.

121    Nor can the Council properly rely on the concept of ‘institutions’ in Article 342 TFEU, according to which ‘the rules governing the languages of the institutions of the Union shall, without prejudice to the provisions contained in the Statute of the Court of Justice of the European Union, be determined by the Council, acting unanimously by means of regulations’. As the Advocate General stated in point 98 of his Opinion in *Italy* v *Council (Seat of the European Medicines Agency)*, *Comune di Milano* v *Council (Seat of the European Medicines Agency)* and *Parliament* v *Council (Seat of the European Labour Authority)* (C‐59/18, C‐182/18 and C‐743/19, EU:C:2021:812), the term ‘institutions’, within the meaning of Article 342 TFEU, need not necessarily be interpreted as including the bodies, offices and agencies of the Union, since the language regime of a body, office or agency of the Union can be different from that in force in the institutions of the Union.

122    As regards Protocol No 6, although, as the Council contends, that protocol determines not only the seat of the institutions of the Union but also that of certain bodies, offices and agencies of the Union, including Europol, and refers to Article 341 TFEU, it does not, however, provide that the seats of bodies, offices and agencies of the Union must be determined collectively by the Member States in accordance with the principle laid down in that article. In that regard, it is important to note that the common feature of those bodies, offices and agencies of the Union in question is that they were established by the Member States, whereas that is not the case with an agency of the Union such as the EMA, which was established, on the basis of the founding Treaties, by the EU legislature. Thus, it cannot be inferred from that protocol that the Member States intended to apply, directly or by analogy, the principle laid down in Article 341 TFEU to the determination of the seat of all the bodies, offices and agencies of the Union.

123    As the Advocate General observed in point 112 of his Opinion in *Italy* v *Council (Seat of the European Medicines Agency)*, *Comune di Milano* v *Council (Seat of the European Medicines Agency)* and *Parliament* v *Council (Seat of the European Labour Authority)* (C‐59/18, C‐182/18 and C‐743/19, EU:C:2021:812), the adoption of a specific protocol shows, on the contrary, that the Member States considered that their collective decision as to the determination of the seat of certain bodies, offices and agencies of the Union exhaustively listed had to be specifically enshrined in primary law in order to produce legal effects in EU law.

124    As regards the express reference in Protocol No 6 to Article 341 TFEU, this can be explained by the fact that that protocol refers primarily to the institutions mentioned in Article 13(1) TEU.

125    On the other hand, it is true, as is apparent from Article 2 of the Edinburgh Decision, that the Representatives of the Governments of the Member States expressed the wish to reserve to themselves decisions concerning the seats of bodies, offices and agencies of the Union in the same way that they are expressly and clearly authorised by Article 341 TFEU to establish the seats of the institutions of the Union. Furthermore, at the intergovernmental conference which led to the adoption of the Treaty of Amsterdam, the text of the Edinburgh Decision was reproduced as a protocol annexed to the EU, EC, ECSC and EAEC Treaties, now Protocol No 6, annexed to the EU, FEU and EAEC Treaties.

126    Nevertheless, first, the sole article of that protocol fixes, in terms comparable to those of Article 1 of the Edinburgh Decision, the seat only of institutions, bodies, offices or agencies of the Union set up by the Member States. Secondly, although the Court recognised that that decision had binding legal force, in the judgment of 1 October 1997, *France* v *Parliament* (C‐345/95, EU:C:1997:450), to which judgment it referred in other subsequent judgments (see, to that effect, judgments of 13 December 2012, *France* v *Parliament*, C‐237/11 and C‐238/11, EU:C:2012:796, paragraphs 36 to 42, and of 2 October 2018, *France* v *Parliament (Exercise of budgetary powers)*, C‐73/17, EU:C:2018:787, paragraph 33), Article 2 of that decision cannot lead to an interpretation of Article 341 TFEU that would run counter to its clear wording.

127    The Council also relies, as a contextual element, on previous institutional practice relating to the determination of the seat of bodies, offices and agencies of the Union and maintains that that practice enjoys ‘institutional recognition’ by means of the 2012 Joint Statement and the common approach annexed thereto.

128    However, it is clear from the information brought to the Court’s attention in the context of the present case that the alleged practice is far from being generalised. The procedures followed with a view to designating the seat of the bodies, offices and agencies of the Union have either been carried out by the Member States alone or have, to varying degrees and on varying grounds, involved the institutions of the Union in their capacity as participants in the legislative procedure or not.

129    Assuming, however, that it were possible, as the Council maintains, to identify an established and consistent previous practice whereby the seats of the bodies, offices and agencies of the Union were systematically determined on the basis of a political choice made by the Representatives of the Governments of the Member States alone, the interpretation of Article 341 TFEU that the Council advocates on the basis of that practice could not enjoy any ‘institutional recognition’ by means of the 2012 Joint Statement and the common approach annexed thereto. That statement, as made clear in the fifth paragraph thereof, is not legally binding and does not, moreover, contain any recognition of any reservation of competence on the part of the Member States as regards determining the seat of the bodies, offices and agencies of the Union.

130    In any event, such a practice, which would run counter to the rules of the FEU Treaty and, in particular, Article 341 TFEU, by extending, notwithstanding its clear wording, the scope of that article to the location of the seat of the bodies, offices and agencies of the Union, could not create a precedent binding on the institutions (see, to that effect, judgment of 6 May 2008, *Parliament* v *Council*, C‐133/06, EU:C:2008:257, paragraph 60 and the case-law cited).

131    In the third and last place, as regards the objective of Article 341 TFEU, this consists in preserving the decision-making powers of the Member States in determining the seat of the institutions of the Union only. Contrary to the position defended by the Council at the hearing, an interpretation of that article to the effect that it does not apply to bodies, offices and agencies of the Union cannot have the effect of completely negating its effectiveness, as the Advocate General observed in point 138 of his Opinion in *Italy* v *Council (Seat of the European Medicines Agency)*, *Comune di Milano* v *Council (Seat of the European Medicines Agency)* and *Parliament* v *Council (Seat of the European Labour Authority)* (C‐59/18, C‐182/18 and C‐743/19, EU:C:2021:812). While it is true that the seat of the institutions of the Union is already determined by primary law, in this case by Protocol No 6, Article 341 TFEU nevertheless remains relevant to any possible future decision modifying the seat of an existing institution or determining the seat of a new institution.

132    In that context, it must be borne in mind that, unlike the institutions of the Union, the establishment and functions of which are, because of their constitutional importance, provided for by the Treaties themselves, the bodies, offices and agencies of the Union, such as the EMA, the object of which is the achievement of the aims of a given EU policy, are not as a general rule established by the Treaties. In those circumstances, their establishment, since it does not derive from primary law, must result from an act of secondary legislation adopted on the basis of the substantive provisions implementing the EU policy in which the body, office or agency concerned is involved and in accordance with the procedures laid down by those provisions.

133    In the absence of further details in that regard in the Treaties, it is likewise for the EU legislature, in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, to determine the seat of a body, office or agency of the Union which it has itself established by an act of secondary legislation adopted on the basis of those provisions, in the same way as it has competence under those provisions to define the powers, organisation and mode of operation of that body, office or agency.

134    The decision on the location of the seat of a body, office or agency of the Union, such as an EU agency is therefore, contrary to the Council’s arguments, consubstantial with the decision on its establishment. The same applies to a decision on the relocation of the seat of such an agency.

135    Admittedly, the determination of the location of the seat of a body, office or agency of the Union may take account of political considerations, such as the need, in locating bodies, offices or agencies of the Union, to ensure a certain geographical balance or to favour Member States which do not yet host the seat of a body, office or agency of the Union.

136    However, the political nature of the decision determining the location of the seat of such a body, office or agency of the Union is not in itself such as to justify that decision falling outside the competence of the EU legislature, which is indeed regularly called upon to make political choices in the exercise of the European Union’s competences (see, to that effect, judgment of 7 September 2016, *Germany* v *Parliament and Council*, C‐113/14, EU:C:2016:635, paragraph 55).

137    Moreover, such a decision must primarily ensure that the tasks entrusted to the body, office or agency of the Union concerned are carried out with a view to achieving the objectives of a given policy.

138    Nor can the Court accept the argument that linking the determination of the seat of a body, office or agency of the Union to the material basis on which that body, office or agency is established is likely, depending on the relevant legal basis, to result in that determination being subject to a qualified majority vote in the Council, and not to a decision taken by common accord of the Representatives of the Governments of the Member States, while making the determination an element of compromise in the context of the legislative debate.

139    As has been pointed out in paragraph 136 above, the fact that the decision determining the location of the seat of a body, office or agency of the Union may have an important political dimension, inasmuch as it must reflect, inter alia, considerations relating to geographical balance, does not preclude that decision from being taken by the EU legislature in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, since that political dimension may in that respect constitute a factor which the EU legislature can take into account in exercising its discretion. It should also be noted that since the EU legislative process is guided, under the second paragraph of Article 1 TEU in conjunction with Article 10(3) TEU, by the principle of transparency with regard to the citizen, recourse to that process is liable to strengthen the democratic foundation of a decision designating the location of the seat of a body, office or agency of the Union, such as the EMA.

140    In addition, and more fundamentally, the fact that a decision, such as that determining the location of the seat of a body, office or agency of the Union, is politically sensitive cannot lead to the powers conferred by the Treaties on the institutions of the Union being modified, nor can it remove the exercise of those powers from the legislative procedures laid down by the Treaties. The determination of the scope of a provision of the Treaties governing a substantive competence of the European Union cannot, therefore, depend on considerations relating to the politically sensitive nature of the matter concerned or to the concern to ensure the effectiveness of an action.

141    It follows from all those considerations, and in particular from the wording of Article 341 TFEU, that that provision cannot be interpreted as governing the designation of the location of the seat of a body, office or agency of the Union such as the EMA.

142    In those circumstances, the competence to determine the location of the seat of that agency lies not with the Member States but with the EU legislature, which must act to that end in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, in this case Article 114 and Article 168(4) TFEU, which provide for recourse to the ordinary legislative procedure.

143    It is in the light of that conclusion that it is necessary to assess, in the second instance, the scope of the decision of 20 November 2017 and to examine whether the Parliament’s prerogatives were respected.

(2)    *The scope of the decision of 20 November 2017 and respect of the Parliament’s prerogatives*

144    The Italian Republic and the Comune di Milano submit, in essence, that the adoption of the decision of 20 November 2017, as such, is detrimental to the Parliament’s prerogatives. At the very least, they argue that the Parliament considered itself bound by that decision.

145    As regards, in the first place, the complaint that the decision of 20 November 2017 was, as such, detrimental to the Parliament’s prerogatives, it is apparent from the grounds set out in paragraphs 111 to 142 above that competence to determine the seat of the bodies, offices and agencies of the Union lies with the EU legislature and not the Member States.

146    The Parliament and the Council’s legislative power, conferred in Article 14(1) TEU and Article 16(1) TEU, which reflects the principle of conferred powers, enshrined in Article 13(2) TEU and, more broadly, the principle of institutional balance, characteristic of the institutional structure of the European Union, means that it is for those institutions alone to decide the content of a measure (judgment of 21 June 2018, *Poland* v *Parliament and Council*, C‐5/16, EU:C:2018:483, paragraph 84 and the case-law cited).

147    Thus, without disregarding the institutional architecture and the division of powers under the Treaties, a decision such as the decision of 20 November 2017, which was adopted by the Member States on the basis of specific substantive and procedural rules agreed by the Member States outside a framework defined under EU law, cannot be given any binding force, capable of limiting the discretion of the EU legislature, even where the Commission was involved in the selection process which led to the adoption of that decision. Such a decision therefore has the force of a measure of political cooperation which cannot in any event encroach on the powers conferred on the institutions of the Union in the context of the ordinary legislative procedure.

148    In that regard, the mere fact that the Parliament was not involved in the process which led to the adoption of the decision of 20 November 2017 cannot be regarded as an infringement or a circumvention of the Parliament’s prerogatives as co-legislator. Apart from the fact that that process took place outside the framework defined by EU law and that that decision has no binding force under EU law, the legislative procedure for determining the location of the new seat of the EMA had not been initiated at the time of its adoption.

149    It follows that the complaint that the adoption of the decision of 20 November 2017, as such, infringed the Parliament’s prerogatives must be rejected.

150    As regards, in the second place, the complaint that the Parliament considered itself bound by the decision of 20 November 2017 and thus waived the right to exercise its powers in legislative matters by limiting its role to purely formal aspects, it is apparent from the file before the Court, first of all, that the proposal which gave rise to the contested regulation, referred to in paragraph 20 of the present judgment, which provided that the city of Amsterdam was to be chosen as the new seat of the EMA, was analysed by several parliamentary committees. Some of those committees, such as the Committee on Budgetary Control and the Committee on Constitutional Affairs, expressed their opinion on that proposal on 11 January 2018 and 26 February 2018, respectively.

151    Next, the debates within the Parliament gave rise to the tabling of amendments, some proposing that a city other than Amsterdam, in particular Milan, should be selected as the seat of the EMA, others suggesting the adoption of new selection criteria and new procedural rules for the choice of that seat. Following the vote in parliamentary committee and then in plenary session, those amendments were, however, rejected in their entirety by the Parliament, which opted for the seat referred to in the Commission’s proposal. Thus, the conduct of the legislative process and the result to which it led show that the possible designation of the city of Milan as the new seat of the EMA was discussed during the parliamentary proceedings before ultimately being rejected.

152    On the other hand, following informal negotiations between the Council and the Parliament, other amendments were adopted concerning the reference to a specific date for the transfer of the seat of the EMA and the establishment of a mechanism for monitoring the progress of the transfer operation. Those additions were subsequently inserted into the text of the contested regulation, as is apparent from recitals 2 and 3 of that regulation.

153    Lastly, the Parliament voted on the draft legislative act on 25 October 2018, taking into account a number of informal exchanges which had taken place between the Council, the Parliament and the Commission with the intention of reaching agreement on the question of the new seat of the EMA at first reading and avoiding the need for a second reading or even a conciliation procedure.

154    It cannot therefore be validly maintained that the Parliament’s intervention was confined to a purely formal role.

155    It is true that, in the declaration annexed to the legislative resolution of 25 October 2018, the Parliament stated that it regretted that ‘its role as co-legislator was not duly taken into account, since it [had] not been involved in the selection procedure for the new seat of the [EMA]’ (first paragraph), wished to ‘recall its prerogatives as co-legislator’, required ‘full respect of the ordinary legislative procedure in relation to the location of bodies and agencies’ (second paragraph) and condemned ‘the procedure followed for the selection of the new location of the seat, which [had] de facto deprived the European Parliament of its prerogatives since it [had] not [been] effectively involved in the process, but [was] now expected to simply confirm the selection made for the new location of the seat by means of the ordinary legislative procedure’ (fourth paragraph).

156    However, it cannot be inferred from that statement that the Parliament took the view that the decision of 20 November 2017 was legally binding. It is true that that decision and the selection process which preceded it may have had significant political importance, having regard in particular to the fact, relied on by the Parliament, that it was imperative to ensure the continuity of the EMA’s activity and, therefore, the designation of a new seat for that agency as soon as possible. That being said, the political impact of that decision on the legislative power of the Parliament and the Council cannot constitute grounds for the annulment by the Court of the contested regulation (see, by analogy, judgments of 6 September 2017, *Slovakia and Hungary* v *Council*, C‐643/15 and C‐647/15, EU:C:2017:631, paragraphs 145 and 149, and of 21 June 2018, *Poland* v *Parliament and Council*, C‐5/16, EU:C:2018:483, paragraphs 85 and 86).

157    Lastly, the reference, in recital 1 of the contested regulation, to the decision of 20 November 2017, is also not capable, in itself, of establishing that the Parliament did not correctly assess the extent of its prerogatives or that those prerogatives were disregarded.

158    It follows that the complaint alleging that the Parliament considered itself bound by the decision of 20 November 2017 must also be rejected.

159    In those circumstances, the first plea in Case C‐106/19 and the first plea in Case C‐232/19 must be rejected.

*The second plea in Case C*‐*106/19 and the second to fourth pleas in Case C*‐*232/19*

–       *Arguments of the parties*

160    By its second plea in Case C‐106/19, the Italian Republic claims that, even if there had not been an infringement of the Parliament’s prerogatives and where, in particular, the contested regulation merely ‘ensures receipt’ of the decision of 20 November 2017, the unlawfulness affecting that decision, called into question in Case C‐59/18, *Italian Republic* v *Council*, vicariously renders that regulation unlawful. Referring to the arguments put forward in that case, the Italian Republic points out that that decision is vitiated by a misuse of powers.

161    By its second to fourth pleas in Case C‐232/19, which overlap with the second plea raised by the Italian Republic in Case C‐106/19, the Comune di Milano also argues that, since the contested regulation is based on the decision of 20 November 2017, the unlawfulness vitiating that decision and the selection process which preceded it affect the lawfulness of that regulation.

162    In the context of the second plea in Case C‐232/19, the Comune di Milano disputes, in the first place, the lawfulness of the selection procedure adopted on 22 June 2017, in so far as it provided for recourse to the drawing of lots in order to decide on the final designation of the location of the seat of the EMA. According to the Comune di Milano, the choice of such an arbitrary designation method constitutes a misuse of powers in that it departs from the objective pursued by the selection procedure, namely to ensure that the best offer for hosting the new seat of the EMA is accepted, having regard to predefined criteria.

163    In the second place, the Comune di Milano submits that the selection procedure is also unlawful because the Commission did not take the information measures provided for the purposes of that procedure, which led to a significant distortion of the Kingdom of the Netherlands’s offer by the Member States which took part in the vote.

164    By its third plea, the Comune di Milano submits that the selection procedure adopted on 22 June 2017 failed to observe the principles of sound administration and sincere cooperation, in so far as it provided for a final drawing of lots, which is not a fitting selection method for a decision-making process of the institutions of the Union. It also claims that that procedure infringed the principle of the transparency of administrative activity, in so far as no minutes of the voting operations were drawn up and, more generally, there was no form of publicity or monitoring of the procedure.

165    Finally, by its fourth and final plea, the Comune di Milano alleges, in essence, infringement of a series of provisions of the Council’s Rules of Procedure relating to the preparation of minutes, the taking of decisions, the form of the acts and the obligation to state reasons. In addition, the Comune di Milano claims that the selection procedure, in particular the ballot stage, was in breach of the rules set out in the note of 31 October 2017, referred to in paragraph 17 above, in particular in so far as that note provided for a 30-minute break between each round of the ballot.

166    The Council contends that the pleas put forward should be rejected, arguing, inter alia, that the Italian Republic and the Comune di Milano are not entitled to challenge the lawfulness of the decision of 20 November 2017.

167    For its part, the Parliament observes that, formally, the Italian Republic’s application does not satisfy, as regards the presentation of the arguments, the conditions laid down in Article 21 of the Statute of the Court of Justice of the European Union and Article 120(c) of the Rules of Procedure. As to the substance, it considers that the pleas raised are ineffective, in the absence of any legal connection between the decision of 20 November 2017 and the contested regulation.

168    The Commission also contends that the pleas put forward should be rejected since the decision of 20 November 2017 is not legally binding.

–       *Findings of the Court*

169    The second plea in Case C‐106/19 and the second to fourth pleas in Case C‐232/19, by which the Italian Republic and the Comune di Milano submit, in essence, that the unlawfulness vitiating the decision of 20 November 2017 has the effect of rendering the contested regulation unlawful, are based on the premiss that there is a legal connection between that decision and that regulation.

170    However, as is apparent from the considerations set out in paragraphs 111 to 142 of the present judgment, competence to determine the location of the seat of bodies, offices and agencies of the Union is not vested in the Member States but in the EU legislature, which exercises that competence in accordance with the procedures laid down by the provisions of the Treaties which are substantively relevant, in the present case as laid down by Article 114 and Article 168(4) TFEU, which provide for recourse to the ordinary legislative procedure. Besides, as was noted in paragraph 147 above, the decision of 20 November 2017 has no binding legal effects under EU law, with the result that it cannot constitute the legal basis of the contested regulation and, moreover, has no legal connection with that regulation.

171    Thus, even if, as the applicants claim, the decision of 20 November 2017 was taken following a flawed procedure and in an unlawful manner, that fact would, in itself, have no effect on the lawfulness of the contested regulation.

172    In those circumstances, the second plea in Case C‐106/19 and the second to fourth pleas in Case C‐232/19 must be rejected as ineffective.

173    Since none of the pleas put forward in support of the present actions has been upheld, those actions must be dismissed in their entirety.

**Costs**

174    Under Article 138(1) of the Rules of Procedure of the Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

175    According to Article 138(3) of the Rules of Procedure, where each party succeeds on some and fails on other heads, the parties must bear their own costs. However, if it appears justified in the circumstances of the case, the Court may order that one party, in addition to bearing its own costs, is to pay a proportion of the costs of the other party.

176    In the present case, characterised by the fact that the circumstances surrounding the adoption of the contested regulation are distinguished by divergent practice and interpretations on the question of decision-making competence in relation to the location of the seats of the bodies and agencies of the Union, it appears justified to order each of the main parties, namely the Italian Republic, the Comune di Milano, the Council and the Parliament, to bear their own costs.

177    In accordance with Article 140(1) of the Rules of Procedure, the Kingdom of the Netherlands and the Commission, as interveners, must bear their own costs.

On those grounds, the Court (Grand Chamber) hereby:

1.      **Dismisses the actions;**

2.      **Orders the Italian Republic, the Council of the European Union and the European Parliament to bear their own costs in Case C**‐**106/19;**

3.      **Orders the Comune di Milano, the Council of the European Union and the European Parliament to bear their own costs in Case C**‐**232/19;**

4.      **Orders the Kingdom of the Netherlands and the European Commission to bear their own costs.**

[Signatures]

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[\*](#Footref*)      Language of the case: Italian.